Phramongkutklao Hospital
Ratchathewi, Bangkok, 10400, Thailand
Location status: Recruiting
NCT Number: NCT06496282
Shift Work Sleep Disorder (SWSD) are caused by working shifts with a wake-up schedule and sleeping in a way that is different from the natural way of sleeping and avoiding sleep usually results in deviations. of the biological clock (Biological clock), which is an important cause of sleep problems including insomnia, excessive sleepiness or daytime sleepiness these problems was associated cadiovascular events, decrease quality of life and long term working. At the present there are limited information regarding the effectiveness of medications used to promote sleep in shift workers. Lemborexant is specific in binding to orexin type 2, which has a direct effect on sleep. and there are limited biomarkers monitoring from the use of lemborexant including still not found. Which studies have followed depressive symptoms, anxiety symptoms and cognition from a group of people with insomnia, the aim of study to assessment effectiveness of lemborexant on sleep efficiency, quality of life, symptoms of depression, cognition, BDNF, CRP, IL-6 and TNF-alpha levels. of volunteers working on rotating shifts.
Interested in participating?
Request Info20 year–60 year
All sexes
Interventional
Phase 3
Ratchathewi, Bangkok, 10400, Thailand
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participants will receive lemborexant for improving sleep quality at lease 30 days in 6 weeks of study
Other names: Dayvigo
The participants will receive placebo for improving sleep quality at lease 30 days in 6 weeks of study
Other names: Dayvigo placebo
Time frame: 1 week after screening, 3 and 6 weeks after lemborexant administration
Sleep quality improvement evaluated by physician with actigraphy (Fitbit inspire 2) after lemborexant administration in 3 and 6 week.
Time frame: 1 week after screening and 6 weeks after lemborexant administration
Blood sample of BDNF changing in 1 week after screening and 6 weeks after lemborexant administration
Time frame: 1 week after screening and 6 weeks after lemborexant administration
Sleepiness level improvement evaluated by physician with Epworth sleepiness scale after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration
Time frame: 1 week after screening and 6 weeks after lemborexant administration
Sleep quality improvement evaluated by physician with Pittsburgh sleep quality index (PSQI) in 1 week after screening and 6 weeks after lemborexant administration
Time frame: 1 week after screening and 6 weeks after lemborexant administration
Depression symptoms improvement evaluated by physician with Hamilton depression rating scale (HAM-D) after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration
Time frame: 1 week after screening and 6 weeks after lemborexant administration
Anxiety symptoms improvement evaluated by physician with Hamilton anxiety rating scale (HAM-A) after lemborexant administration in 1 week after screening and 6 weeks after lemborexant administration
Time frame: 1 week after screening and 6 weeks after lemborexant administration
Cognition improvement evaluated by physician with Motreal cognitive assessment (MOCA), Grooved pegboard test and Digit symbol substitution test in1 week after screening and 6 weeks after lemborexant administration
Time frame: 1 week after screening and 6 weeks after lemborexant administration
Quality of life improvement evaluated by physician with EuroQOL five dimensions questionnaires (EQ-5D )in 1 week after screening and 6 weeks after lemborexant administration
Time frame: 1 week after screening and 6 weeks after lemborexant administration
Blood sample of CRP, IL-6 and TNF-alpha changing in 1 week after screening and 6 weeks after lemborexant administration
Interested in participating?
Request InfoPhramongkutklao College of Medicine and Hospital
Other
The Efficacy of Lemborexant Versus Placebo on Improving Sleep Quality Among Hospital Rotating Shift Workers: A Randomized, Double-Blind, Placebo-Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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